Asthma in ChildrenNCT06053905
Dynamic Respiratory Muscle Strength and Endurance in Childhood Asthma
An observational study of Asthma in Children, run by Bartın Unıversity at 1 site in Turkey (Türkiye).
Trial summary
Peak inspiratory flow (PIF) may be due to respiratory muscle strength, especially in those with severe airflow obstruction. PIF appears to be lower in children and adolescents with asthma than in non-asthmatics and correlates positively with age, height, weight, and respiratory muscle strength. Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma in Children
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Mar 2023to 10 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: asthmatic child and healthly peers
Who may be able to join
- Hacettepe University Faculty of Medicine, Department of Pediatrics, Allergy and Asthma Unit patients referred for Cardiopulmonary Rehabilitation,
- Those who have been diagnosed with asthma,
- Clinically stable and not in active asthma attack,
- Between the ages of 6-11,
- Giving consent on a voluntary basis,
- cooperative,
Show all 24Show fewer
- Asthmatic Group Exclusion Criteria:
- Those whose clinical status is not stable and who are in active asthma attack,
- Having serious diseases such as cancers, heart failure and acute respiratory infections,
- Having chronic lung disease other than asthma,
- Severe neuromuscular and musculoskeletal problems,
- Uncooperative to do the tests,
- For safety reasons, patients admitted or hospitalized in the last 3 months due to an asthma attack will not be included in the study.
- Healthy Group Inclusion Criteria:
- Not having any chronic disease for healthy individuals,
- be between the ages of 6-11,
- Volunteering to participate in the study,
- Not having speech and hearing problems,
- Being cooperative,
- Not having a mental, neurological, orthopedic, cardiovascular or pulmonary problem that would prevent physical activity,
- Healthy Group Exclusion Criteria:
- The presence of a medical indication that requires complete restriction of physical activity,
- Having symptoms of any chronic or acute illness involving the lungs
- Existence of cooperation and communication problems
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Dynamic Respiratory Muscle Strength and Endurance, Physical Activity Level and Physical Fitness in Asthmatic Children and Their Healthy Peers
Peak inspiratory flow (PIF) may be due to respiratory muscle strength, especially in those with severe airflow obstruction. PIF appears to be lower in children and adolescents with asthma than in non-asthmatics and correlates positively with age, height, weight, and respiratory muscle strength. Although physical activity and fitness are also believed to be important in lung health, the relationship between lung function and physical fitness is unclear. It measures dynamic lung volumes, s-index and PIF and provides information on dynamic lung function in children and adolescents. In this study, the dynamic components of the lung will be compared between asthmatic and healthy children, and the relationship between respiratory parameters and physical assessment, such as physical fitness, activity and functional capacity, will be investigated in children with asthma.
Read the detailed description
Asthma prevalence is high in childhood and adolescence and the disease imposes an economic burden. In studies, patients with peak inspiratory flow (PIF) showed variability in severe obstruction and a dependence on respiratory muscle strength. PIF appears to be lower in children and adolescents with asthma than in those without asthma and correlates positively with age, height, weight and respiratory muscle strength. Also, although physical activity and fitness are believed to be important in lung health, the relationship between lung function and physical fitness is unclear. Physical activity improves exercise capacity and outcomes in patients with asthma or chronic obstructive pulmonary disease, but there is insufficient evidence that it improves lung function. Physical fitness in childhood and adolescence has been associated with increases in lung volumes throughout early adulthood. These relationships may weaken with age and may not be significant in older age groups. s-Index (a special calculation) and PIF describe dynamic lung volumes. There are very few studies in the literature that dynamically evaluate respiratory muscles and functions compared to their healthy counterparts and interpret these tests together with physical evaluations. In addition, reference values for the s-index and PIF in children with asthma are uncertain due to the small number of studies. The results of this study will contribute to future studies in determining the test reference values.The investigators think that the results of the study will contribute to future studies in determining the test reference values.
- Conditions
- Asthma in Children
- Keywords
- Asthma Childhood, Respiratory Muscle, Physical Activity, Fitness
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Asthmatic Child | Children with asthma between 6-11 years old | |
| Healthy Controls Group | Healthy children between 6-11 years old |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic Respiratory Muscle Strength and Endurance
POWERbreathe K-Series, K5, intelligent digital breathing trainers, The first 2 breaths should be taken as quickly and deeply as possible. During these breaths, the maximum respiratory capacity is measured. The index of the power indicator ranges from 10 to 240 cm H2O. Higher values are better. For hygiene reasons, the test is done with a disposable mouthpiece.
Measured: Day 1
Pulmonary Function Test
It is evaluated with the Pulmonary Function Test. After a deep, full inspiration, a forced expiratory maneuver is performed. Used with disposable antiviral filter. The patient's height and body weight are measured and recorded with age. It is done 3 times, there should be no more than 10% difference between the values. The highest value is accepted.
Measured: Day 1
Secondary outcomes (7)
6 Minutes Walking Test
Six munite walk test It will be measured with the 6 Minute Walk Test. You can walk for 6 minutes at a fast pace without running in the 30 m long corridor. The six minute walk test will be measured by the 6 Minute Walk Test. You can walk at a fast pace for 6 minutes without running in a 30 m long corridor. The distance walked is recorded in meters.
Measured: Day 1
Physical Activity Questionnaire
It is a 5-point liket questionnaire consisting of 10 questions created to determine the physical activity level of children for the last 1 week.
Measured: Day 1
FITNESSGRAM (a) Sit and lie down test with back support:
FITNESSGRAM is a physical fitness test with its own guide. There are cut-off values according to age and gender.
(a) Sit and lie down test with back support: While sitting, the person extends his foot and bends the other lower extremity. The hands are stretched forward four times in a row and the fourth distance is recorded.
Measured: Day 1
FITNESSGRAM (b) Trunk Extension-extension test:
(b) Trunk Extension-extension test: The person lies face down with the hands under the thighs. He lifts his body twice, looking at a coin. In the second, the distance between the chin and the cushion is recorded.
Measured: Day 1
FITNESSGRAM (c) Trunk Flexion flexion test:
(c) Trunk Flexion flexion test: The person lies on his back with the knees bent and touches the fixed band on the sides at hand level with the fingertips. Lifts the trunk in a repeat rhythm (every three seconds). It does not move from the lane while rubbing its hands. The number of repetitions performed correctly in accordance with the rhythm is noted.
Measured: Day 1
FITNESSGRAM (d) Push-up test:
(d) Push-up test: The person is face down and the hands are shoulder-width apart. The chest moves up and down, with the elbows locked and unlocked (every three seconds) without bending the body. The number of repetitions is noted.
Measured: Day1
FITNESSGRAM (e) PACER test
(PACER test): The PACER test is a progressive aerobic cardiovascular endurance run. It is done on a 20-meter course. He jogs at an accelerating rhythm (decreasing by half a second every minute). The test ends if the rhythm is missed or the line is not reached before two beeps. The number of laps is recorded.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start13 Mar 2023
- Primary completion13 Dec 2023
- Study completion10 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bartın Unıversity
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University
- Responsible party
- Principal investigator, Şeyma Nur Önal, Bartın Unıversity
- Investigators
- Ebru Calik Kutukcu, PhD, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06053905
- Sponsor's protocol ID
- GO23/241
- Status last verified
- Aug 2024
- First submitted
- 9 Aug 2023
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dynamic Respiratory Muscle Strength and Endurance, Physical Activity Level and Physical Fitness in Asthmatic Children and Their Healthy Peers
- ClinicalTrials.gov ID
- NCT06053905
- Acronym / sponsor ID
- GO23/241
- Conditions
- Asthma in Children
- Keywords
- Asthma Childhood, Respiratory Muscle, Physical Activity, Fitness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bartın UnıversityUniversity, hospital or other
- Collaborators
- Hacettepe University
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 13 Dec 2023 (actual)
- Study completion
- 10 Mar 2024 (actual)
- First posted
- 26 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Peak inspiratory flow (PIF) may be due to respiratory muscle strength, especially in those with severe airflow obstruction. PIF appears to be lower in children and adolescents with asthma than in non-asthmatics and correlates positively with age, height, weight, and respiratory muscle strength. Although physical activity and fitness are also believed to be important in lung health, the relationship between lung function and physical fitness is unclear. It measures dynamic lung volumes, s-index and PIF and provides information on dynamic lung function in children and adolescents. In this study, the dynamic components of the lung will be compared between asthmatic and healthy children, and the relationship between respiratory parameters and physical assessment, such as physical fitness, activity and functional capacity, will be investigated in children with asthma.
Detailed description
Asthma prevalence is high in childhood and adolescence and the disease imposes an economic burden. In studies, patients with peak inspiratory flow (PIF) showed variability in severe obstruction and a dependence on respiratory muscle strength. PIF appears to be lower in children and adolescents with asthma than in those without asthma and correlates positively with age, height, weight and respiratory muscle strength. Also, although physical activity and fitness are believed to be important in lung health, the relationship between lung function and physical fitness is unclear. Physical activity improves exercise capacity and outcomes in patients with asthma or chronic obstructive pulmonary disease, but there is insufficient evidence that it improves lung function. Physical fitness in childhood and adolescence has been associated with increases in lung volumes throughout early adulthood. These relationships may weaken with age and may not be significant in older age groups. s-Index (a special calculation) and PIF describe dynamic lung volumes. There are very few studies in the literature that dynamically evaluate respiratory muscles and functions compared to their healthy counterparts and interpret these tests together with physical evaluations. In addition, reference values for the s-index and PIF in children with asthma are uncertain due to the small number of studies. The results of this study will contribute to future studies in determining the test reference values.The investigators think that the results of the study will contribute to future studies in determining the test reference values.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthmatic Child | – | –Children with asthma between 6-11 years old |
| Healthy Controls Group | – | –Healthy children between 6-11 years old |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- asthmatic child and healthly peers
Key inclusion criteria (24 listed)
- Hacettepe University Faculty of Medicine, Department of Pediatrics, Allergy and Asthma Unit patients referred for Cardiopulmonary Rehabilitation,
- Those who have been diagnosed with asthma,
- Clinically stable and not in active asthma attack,
- Between the ages of 6-11,
- Giving consent on a voluntary basis,
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dynamic Respiratory Muscle Strength and Endurance
Time frame: Day 1
POWERbreathe K-Series, K5, intelligent digital breathing trainers, The first 2 breaths should be taken as quickly and deeply as possible. During these breaths, the maximum respiratory capacity is measured. The index of the power indicator ranges from 10 to 240 cm H2O. Higher values are better. For hygiene reasons, the test is done with a disposable mouthpiece.
Pulmonary Function Test
Time frame: Day 1
It is evaluated with the Pulmonary Function Test. After a deep, full inspiration, a forced expiratory maneuver is performed. Used with disposable antiviral filter. The patient's height and body weight are measured and recorded with age. It is done 3 times, there should be no more than 10% difference between the values. The highest value is accepted.
7 secondary outcomes
6 Minutes Walking Test
Time frame: Day 1
Physical Activity Questionnaire
Time frame: Day 1
FITNESSGRAM (a) Sit and lie down test with back support:
Time frame: Day 1
FITNESSGRAM (b) Trunk Extension-extension test:
Time frame: Day 1
FITNESSGRAM (c) Trunk Flexion flexion test:
Time frame: Day 1
FITNESSGRAM (d) Push-up test:
Time frame: Day1
FITNESSGRAM (e) PACER test
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ebru Calik Kutukcu, PhD principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma in Children, run by Bartın Unıversity at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic Respiratory Muscle Strength and Endurance (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.